Safety Alerts & Recalls
What does this mean?
If you are taking a fluoroquinolone antibiotic, it's a good idea to follow-up with your healthcare provider to review the risks and benefits of your medicine in your situation. You can also find more information about the medicine in the Medication Guide that is provided with the prescription.
Please contact your health care professional immediately if you experience any serious side effects while taking your fluoroquinolone medicine. Some signs and symptoms of serious side effects include tendon, joint and muscle pain, a “pins and needles” tingling or pricking sensation, confusion, and hallucinations. If you have any questions or concerns about this alert or your medicine, please talk with your healthcare provider.
Patients and healthcare providers are encouraged to report side effects related to the use of medicines to the FDA's MedWatch program. You can reach MedWatch by:
--- Telephone: 1-800-332-1088
--- Fax: 1-800-332-0178
--- Mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787
--- Website: http://www.fda.gov/Safety/MedWatch/default.htm
FDA Advises Avoiding Use of Fluoroquinolone Antibiotics in Certain Uncomplicated Infections Due to Disabling Side Effects That Can Occur
The U.S. Food and Drug Administration (FDA) has issued a warning that the serious side effects associated with fluoroquinolone antibiotic drugs generally outweigh the benefits for patients with acute sinusitis, acute bronchitis, and uncomplicated urinary tract infections who have other treatment options. For patients with these conditions, fluoroquinolones should only be used for those who do not have other treatment options.
An FDA safety review has shown that fluoroquinolones when used systemically (i.e. tablets, capsules, and injectable) are associated with disabling and potentially permanent serious side effects that can occur together. These side effects can involve the tendons, muscles, joints, nerves, and central nervous system.
Fluoroquinolone antibiotics include moxifloxacin (Avelox), ciprofloxacin (Cipro), gemifloxacin (Factive), levofloxacin (Levaquin), and ofloxacin. The drug labels and Medication Guides for these drugs will be updated to include this new safety information.
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